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FDA Purple Book · Reference family

efbemalenograstim alfa-vuxw (Ryzneuta)

efbemalenograstim alfa-vuxw is an FDA-licensed reference biologic from Evive Biotechnology Singapore PTE. LTD.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2023

Reference approved

Reference product

351(a)BLA 761134

Ryzneuta efbemalenograstim alfa-vuxw

Evive Biotechnology Singapore PTE. LTD.

Approved
Nov 16, 2023
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for efbemalenograstim alfa-vuxw, in chronological order.

  1. Reference approval

    Approval date of the reference efbemalenograstim alfa-vuxw product.

    2 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for efbemalenograstim alfa-vuxw (Ryzneuta)?

No 351(k) biosimilars or interchangeable biosimilars referencing efbemalenograstim alfa-vuxw are listed in the FDA Purple Book yet.

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